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The FDA at the moment regulates all surgical robots as Class II (average risk) devices, which follows the precedent established because of the clearance of prior Amount 1 robotic systems11. The FDA viewed as most surgical robots through the 510(k) Premarket Notification pathway, which necessitates an illustration of substantial equivalence to a lawfully promoted system or “predicate” via non-clinical testing14. 5 robotic systems—the AquaBeam Robotic Procedure

three. Determination-Making: Deciding on an appropriate motion or series of actions based upon analysis and predefined targets.

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